BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3193321 · Received June 25, 2013

    Report

    Report Number
    2024601-2013-00564
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    April 12, 2011
    Report Date
    May 31, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF IT IS EXPLANTED IN THE FUTURE. THE DEVICE WAS REPOSITIONED/REPAIR AND REMAINS IMPLANTED. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REPOSITIONED/REPAIRED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CAUTION: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. FAILURE TO DO SO MAY RESULT IN THE INABILITY TO PERFORM PERCUTANEOUS BAND ADJUSTMENTS." "ACCESS PORTS HAVE BEEN REPORTED TO BE "FLIPPED" OR INVERTED. IF YOU INITIALLY SEE AN OBLIQUE OR SIDE VIEW ON X-RAY, THEN EITHER REPOSITION THE PATIENT OR THE X-RAY EQUIPMENT UNTIL YOU OBTAIN A PERPENDICULAR, OVERHEAD (0 DEGREE) VIEW. TARGETING THE PORT FOR NEEDLE PENETRATION CAN BE DIFFICULT IF THIS ORIENTATION IS NOT CONTROLLED. BE AWARE THAT AN UPSIDE DOWN (180 DEGREE) PORT SHOWS THE SAME IMAGE."

    Description of Event or Problem · 1

    PHYSICIAN REPORTED "THE TUBING PROXIMAL TO THE BAND HAD BECOME BRITTLE AND WAS LEAKING, [THE SURGEON] MANAGED TO TRIM THE TUBING AND REPAIR USING AN ACCESS PORT KIT." INVESTIGATION IN PROGRESS. FOLLOW-UP FINDINGS: "PATIENT HAD PRIMARY BAND [APPROXIMATELY SIX YEARS AGO] AND HAD A PORT FLIP THAT WAS REPOSITIONED [TWO YEARS AGO]. PATIENT REPRESENTED WITH SECOND OCCURRENCE WITH NO SATIETY [SIX MONTHS AGO] AND FILL VOLUME WAS CHECKED, A WHILE LATER THE FILL VOLUME WAS RECHECKED AND FOUND TO BE LESS THAN RECORDED AND IT WAS PRESUMED THAT THERE WAS A LEAK AT THE PORT. DURING REVISION SURGERY AFTER LAPAROTOMY THE SURGEON COULD NOT FIND ANY LEAK PROXIMAL TO THE ACCESS PORT II. WHILE THE SURGEON WAS TESTING THE ACCESS PORT FOR LEAKS THE TUBING DETACHED AND IT WAS OBSERVED THAT THE TUBING PROXIMAL TO THE BREAK WAS BRITTLE. THE SURGEON THEN PERFORMED A LAPAROSCOPY WITH 1 X SCOPE AND X 5MM TROCAR AND WAS ABLE TO GRASP THE TUBING STILL ATTACHED TO THE BANK AND WAS ABLE TO PULL A FEW CENTIMETERS OF THE TUBING THROUGH THE TROCAR INCISION. THE FRIABLE PART OF THE TUBING WAS THEN TRIMMED BACK AND AN ACCESS PORT II KIT WAS OPENED AND WITH THE SPARE TUBING THE BAND WAS REPAIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288093 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR